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OpenTrials
Completed

NCT Number: NCT00186264

Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

The primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

Participants will be treated with Venlafaxine XR for 6 weeks. The dose of Venlafaxine XR will begin at 37.5 mg/day and be gradually increased to a maximum of 225 mg/day. The dose may be kept as low as 75 mg/day if necessary. Study doctor will be assessing mood to determine if some patients respond more quickly than the several weeks often required for an antidepressant to begin working. On the first day of treatment with Venlafaxine XR, participant will be randomly assigned (similar to a flip of a coin) to receive hydrocortisone 15 mg /day or placebo for two days. Placebo is an inactive substance, like a sugar pill. This dose of hydrocortisone is less than a typical replacement dose for patients who are not producing cortisol (hydrocortisone) naturally. The hydrocortisone is administered intravenously (in a vein) over the course of 2 hours for two consecutive days. Neither participant nor study doctor will know which treatment participant is receiving. However, this information is available to study doctor if it is needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

:- outpatients at least 18 years of age

  • current major depressive episode
  • HDRS greater than or equal to 21
  • good physical health Exclusion Criteria:- history of sensitivity, intolerance, or non-response to venlafaxine
  • history of sensitivity to hydrocortisone
  • history of bipolar 1 illness
  • meets DSM-IV criteria for a current or past psychotic disorder
  • meets DSM-IV criteria for substance abuse or dependence in previous 6 months
  • significant imminent suicide risk
  • medical condition that would compromise participation in the study
  • woman of child bearing potential not using adequate birth control in the opinion of the investigator

Treatment and study plan

venlafaxine XR

Drug

Hydrocortisone

Drug

Primary outcomes

  1. To determine if treatment of major depression with hydrocortisone concurrent with starting venlafaxine XR speeds onset of antidepressant action.

Secondary outcomes

  1. To determine if hydrocortisone pre-treatment augments venlafaxine XR response.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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